Here Today
4 meses hace
Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap
MALVERN, Pa.
July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.
In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.
The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process.
XenaLives
5 meses hace
So checking out Seeking Alpha today....
[Three things to note here:
The "dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population" (n=523) is an inverse one, i.e., 10mg improved more than 20mg.
This inverse "dose-dependent" improvement in cognition occurs in the overall enrolled patients (n=523), but is reversed in the "Mild Dementia MMSE 20-26" subgroup, where the 10mg group has no statistically significant improvement.
MMSE improvement data is the only data reported from the entire enrolled patients (n=523) in the PR./quote]
https://seekingalpha.com/article/4702593-annovis-bio-a-close-look-at-their-parkinsons-trial-data
I've been following Anavex for years, and I believe their approach is better,
Anavex Life Sciences Reports New Mechanism of Action Data Related to ANAVEX Compounds Targeting Sigma-1 Receptor
?
?
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announced today the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the AD/PDTM 2017 Meeting.
Hall H et al presented preclinical data indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases like Alzheimer’s and Parkinson’s disease, synaptogenesis is believed to be impaired.
Goguadze N et al presented preclinical data indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 also demonstrated protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions. The mitochondrial enzyme complex IV is directly involved in the synthesis of ATP, which provides energy within cells for metabolism. It is believed that energy production impairment and mitochondrial dysfunction play a role in the pathogenesis of neurodegenerative disorders and neurodevelopmental diseases.
“These new results provide converging evidence on mechanism of action as well as possible disease-modifying properties potentially by restoring homeostasis by means of the sigma-1 receptor agonists in our pipeline. This data also provides a foundation for our ongoing translational research efforts,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
Both data sets described that Aß1-42 (amyloid beta) significantly impairs biological function in the respective animal models and the observed regain of function confirmed the protective potential of ANAVEX sigma-1 receptor agonists against amyloid beta -induced toxicity. The former presentation further reported that although that the transgenic McGill rats had a very late stage of Alzheimer’s disease-like pathology (13 months of age), treatment with ANAVEX 3-71 fully reversed cognitive deficits, reduced amyloid pathology and also significantly reduced inflammation. Furthermore, the sustained recovery in cognition and pathophysiology observed following a month-long washout phase in advanced pathology (19 months of age) strongly suggests true disease-modifying properties of ANAVEX 3-71.
AI agrees with me -
query:
does clearing amyloid plaque stop alzheimer's disease
Search Labs | AI Overview
Learn more
…
No, clearing amyloid plaque alone is not likely to stop Alzheimer's disease. While amyloid plaque buildup is a hallmark of Alzheimer's disease, researchers believe that other factors also contribute to its progression, such as tau protein tangles, immune function, and vascular health. In fact, some research suggests that 25% of people with a clinical diagnosis of Alzheimer's disease have little to no amyloid in their brains.
XenaLives
5 meses hace
The chart shows 5 minutes, apparently some trades were voided...
07/09/24 09:42:17 14.6342 14.55 14.85 505
07/09/24 09:42:16 14.60 14.55 14.90 1,406
07/09/24 09:42:15 14.7217 14.55 14.90 50
07/09/24 09:42:13 14.7217 14.55 14.90 25
07/09/24 09:42:13 14.7217 14.55 14.90 169
07/09/24 09:42:11 14.68 14.50 14.90 1,111
07/09/24 09:42:09 14.835 14.77 14.90 200
07/09/24 09:42:08 14.8947 14.77 14.90 25
07/09/24 09:42:08 14.8947 14.77 14.90 1,111
07/09/24 09:42:06 14.78 14.77 14.78 101
07/09/24 09:42:05 14.78 14.77 14.90 2,848
07/09/24 09:42:03 14.79 14.77 14.90 1,941
07/09/24 09:42:02 14.7788 14.77 14.78 213
07/09/24 09:42:01 14.77 14.77 14.78 105
07/09/24 09:42:00 14.77 14.77 14.78 1,123
07/09/24 09:41:59 14.77 14.77 14.78 2,425
07/09/24 09:41:58 14.835 14.77 14.90 538
07/09/24 09:41:57 14.77 14.77 14.90 4,220
07/09/24 09:41:55 14.999 14.93 15.00 25
07/09/24 09:41:53 14.999 14.93 15.00 400
07/09/24 09:41:52 14.9999 14.93 15.00 50
07/09/24 09:41:52 14.9999 14.93 15.00 4,504
07/09/24 09:41:51 14.965 14.93 15.00 1,359
07/09/24 09:41:50 14.97 14.93 15.00 1,411
07/09/24 09:41:48 14.9427 14.93 15.00 2,766
07/09/24 09:41:47 14.99 14.93 15.00 301
07/09/24 09:41:46 14.98 14.85 15.00 150
07/09/24 09:41:45 15.00 14.85 15.00 3
07/09/24 09:41:45 15.00 14.85 15.00 1,389
07/09/24 09:41:43 14.91 14.85 14.99 20
07/09/24 09:41:40 14.91 14.85 14.97 50
07/09/24 09:41:40 14.91 14.85 14.97 50
07/09/24 09:41:40 14.91 14.85 14.97 1,551
07/09/24 09:41:39 14.97 14.85 14.97 535
07/09/24 09:41:37 14.96 14.77 14.97 600
07/09/24 09:41:36 14.95 14.77 14.97 1,250
07/09/24 09:41:36 14.7701 14.77 14.97 399
07/09/24 09:41:34 14.7801 14.77 14.97 968
07/09/24 09:41:33 14.95 14.77 14.97 1,000
07/09/24 09:41:33 14.94 14.77 14.97 609
07/09/24 09:41:31 14.96 14.77 14.97 205
07/09/24 09:41:30 14.875 14.77 14.97 1,476
07/09/24 09:41:29 14.77 14.77 14.98 202
07/09/24 09:41:28 14.97 14.77 14.98 5,927
07/09/24 09:41:27 14.76 14.51 14.77 1,400
07/09/24 09:41:26 14.70 14.51 14.77 155
07/09/24 09:41:25 14.7037 14.51 14.77 1,309
07/09/24 09:41:24 14.666 14.51 14.77 300
07/09/24 09:41:23 14.71 14.51 14.77 1,049
07/09/24 09:41:22 14.60 14.50 14.77 100
07/09/24 09:41:21 14.62 14.50 14.77 63
07/09/24 09:41:19 14.62 14.47 14.77 1,562
07/09/24 09:41:19 14.60 14.47 14.77 678
07/09/24 09:41:18 14.62 14.47 14.77 200
07/09/24 09:41:17 14.66 14.47 14.77 963
07/09/24 09:41:16 14.65 14.47 14.70 1,637
07/09/24 09:41:14 14.55 14.47 14.65 2
07/09/24 09:41:14 14.55 14.47 14.65 4,772
07/09/24 09:41:13 14.58 14.45 14.65 181
07/09/24 09:41:12 14.513 14.45 14.65 3,101
07/09/24 09:41:11 14.435 14.40 14.41 135
07/09/24 09:41:10 14.435 14.40 14.47 570
07/09/24 09:41:09 14.435 14.40 14.47 4,895
07/09/24 09:41:08 14.435 14.40 14.47 546
07/09/24 09:41:06 14.47 14.40 14.47 371
07/09/24 09:41:06 14.435 14.40 14.47 1,172
07/09/24 09:41:05 14.41 14.40 14.47 137
07/09/24 09:41:04 14.4683 14.40 14.47 485
07/09/24 09:41:02 14.43 14.40 14.47 100
07/09/24 09:41:02 14.28 14.27 14.47 206
07/09/24 09:41:01 14.3337 14.27 14.40 2
07/09/24 09:41:00 14.3337 14.27 14.40 1
07/09/24 09:40:58 14.3337 14.27 14.40 101
07/09/24 09:40:56 14.3999 14.27 14.40 25
07/09/24 09:40:56 14.3999 14.27 14.40 2,622
07/09/24 09:40:55 14.40 14.27 14.40 104
07/09/24 09:40:55 14.2701 14.27 14.40 650
07/09/24 09:40:53 14.30 14.20 14.40 76
07/09/24 09:40:51 14.30 14.20 14.40 37
07/09/24 09:40:50 14.30 14.20 14.40 154
07/09/24 09:40:50 14.30 14.20 14.40 410
07/09/24 09:40:48 14.295 14.20 14.40 21
07/09/24 09:40:48 14.295 14.20 14.40 1,994
07/09/24 09:40:46 14.3278 14.29 14.40 126
07/09/24 09:40:43 14.3278 14.29 14.40 20
07/09/24 09:40:43 14.3278 14.29 14.40 18
07/09/24 09:40:43 14.3278 14.29 14.40 355
07/09/24 09:40:42 14.35 14.29 14.40 39
07/09/24 09:40:40 14.35 14.29 14.40 110
07/09/24 09:40:40 14.2001 14.29 14.40 1,200
07/09/24 09:40:39 14.25 14.20 14.30 45
07/09/24 09:40:37 14.25 14.20 14.30 620
07/09/24 09:40:37 14.31 14.20 14.30 3,651
07/09/24 09:40:35 14.385 14.30 14.47 412
07/09/24 09:40:34 14.40 14.28 14.47 129
07/09/24 09:40:32 14.45 14.28 14.47 16
07/09/24 09:40:32 14.45 14.28 14.47 50
07/09/24 09:40:31 14.45 14.28 14.47 31
07/09/24 09:40:30 14.45 14.28 14.47 354
07/09/24 09:40:29 14.30 14.21 14.47 3,700
07/09/24 09:40:27 14.289 14.20 14.29 1,200
07/09/24 09:40:26 14.24 14.20 14.29 243
07/09/24 09:40:25 14.20 14.19 14.29 90
07/09/24 09:40:24 14.20 14.19 14.29 816
07/09/24 09:40:22 14.15 14.10 14.20 401
07/09/24 09:40:22 14.199 14.10 14.20 2,491
07/09/24 09:40:21 14.12 14.10 14.20 25
07/09/24 09:40:20 14.12 14.02 14.20 1,134
07/09/24 09:40:19 14.1999 14.02 14.20 4,300
07/09/24 09:40:17 14.11 14.02 14.20 674
07/09/24 09:40:17 14.13 14.09 14.20 151
07/09/24 09:40:16 14.145 14.09 14.20 106
07/09/24 09:40:14 14.17 14.09 14.20 10
07/09/24 09:40:14 14.17 14.09 14.20 700
07/09/24 09:40:13 14.09 14.09 14.20 610
07/09/24 09:40:10 14.155 14.02 14.20 1
07/09/24 09:40:10 14.155 14.02 14.20 1,070
07/09/24 09:40:08 14.15 14.02 14.29 191
07/09/24 09:40:08 14.1352 14.02 14.29 2,718
07/09/24 09:40:07 14.19 14.10 14.29 2,194
07/09/24 09:40:05 14.155 14.02 14.29 725
07/09/24 09:40:01 14.155 14.02 14.29 20
07/09/24 09:40:01 14.155 14.02 14.29 3
07/09/24 09:40:01 14.155 14.02 14.29 71
07/09/24 09:40:01 14.155 14.02 14.29 586
07/09/24 09:40:01 14.02 14.02 14.29 935
07/09/24 09:40:00 14.281 14.19 14.29 951
07/09/24 09:39:59 14.29 14.19 14.29 1,538
07/09/24 09:39:57 14.17 14.19 14.29 616
07/09/24 09:39:56 14.105 14.02 14.19 100
07/09/24 09:39:56 14.0217 14.02 14.19 1,052
07/09/24 09:39:55 14.105 14.02 14.19 991
07/09/24 09:39:53 14.105 14.02 14.19 301
07/09/24 09:39:53 14.07 14.02 14.19 1,473
07/09/24 09:39:51 14.145 14.10 14.19 216
07/09/24 09:39:51 14.15 14.10 14.19 6,350
07/09/24 09:39:50 13.89 13.87 13.90 1,109
07/09/24 09:39:48 13.87 13.85 13.89 1,521
07/09/24 09:39:47 13.82 13.75 13.89 3,495
07/09/24 09:39:47 13.76 13.75 13.85 1,550
07/09/24 09:39:46 13.77 13.75 13.79 200
07/09/24 09:39:45 13.77 13.75 13.79 2,932
07/09/24 09:39:43 13.76 13.75 13.85 702
07/09/24 09:39:42 13.80 13.75 13.89 2,159
07/09/24 09:39:40 13.89 13.75 13.90 407
07/09/24 09:39:39 13.90 13.75 13.90 2,737
07/09/24 09:39:38 13.84 13.75 13.90 2,400
07/09/24 09:39:37 13.7901 13.75 13.80 329
07/09/24 09:39:36 13.81 13.75 13.90 40
07/09/24 09:39:35 13.81 13.75 13.90 332
07/09/24 09:39:35 13.80 13.75 13.90 3,335
07/09/24 09:39:33 13.7701 13.77 13.90 3,487
07/09/24 09:39:32 13.7501 13.75 13.76 266
07/09/24 09:39:30 13.7501 13.75 13.76 10
07/09/24 09:39:30 13.7501 13.75 13.76 446
07/09/24 09:39:29 13.76 13.75 13.90 1,312
07/09/24 09:39:28 13.7935 13.75 13.90 16,889
07/09/24 09:34:10 13.95 13.52 14.85 125
07/09/24 09:34:08 13.95 13.94 13.95 102
07/09/24 09:34:07 13.95 13.94 13.95 10
07/09/24 09:34:06 13.95 13.94 13.95 52
07/09/24 09:34:05 13.95 13.94 13.95 101
07/09/24 09:34:03 13.95 13.94 13.95 501
07/09/24 09:34:03 13.95 13.94 13.95 25
07/09/24 09:34:02 13.95 13.92 13.95 191
07/09/24 09:34:01 13.95 13.92 13.95 137
07/09/24 09:34:00 13.95 13.92 13.95 100
07/09/24 09:33:59 13.95 13.92 13.95 200
07/09/24 09:33:58 13.95 13.92 13.95 1,730
07/09/24 09:33:56 13.95 13.92 13.95 218
07/09/24 09:33:55 13.96 13.92 13.95 25
07/09/24 09:33:54 13.96 13.92 14.28 61
07/09/24 09:33:54 13.96 13.92 14.28 2,784
07/09/24 09:33:51 13.96 13.92 14.29 160
07/09/24 09:33:51 13.96 13.92 14.29 2,427
07/09/24 09:33:51 13.95 13.92 14.00 4,716
07/09/24 09:33:49 13.95 13.92 13.95 3,217
07/09/24 09:33:48 13.95 13.92 13.95 16,076
07/09/24 09:33:47 14.50 14.49 14.81 200
07/09/24 09:33:46 14.4901 14.49 14.81 4,481
07/09/24 09:33:45 14.64 14.49 14.80 5,105
07/09/24 09:33:44 14.66 14.52 14.81 25,949
07/09/24 09:33:42 15.15 15.09 15.24 600
07/09/24 09:33:41 15.09 15.15 15.24 109
07/09/24 09:33:41 15.09 15.09 15.24 115